Systems, devices, and methods for securing tissue using hard anchors

ABSTRACT

Systems, devices, and methods are provided for securing soft tissue to bone. One exemplary embodiment of a device includes an anchor, a repair filament, and a connecting filament that is coupled to the repair filament, is in contact with the anchor&#39;s distal end, and is effective to connect the repair filament to the anchor such that the repair filament slides with respect to the anchor. The anchor can be rigid, and can include an axial bore extending therethrough. At least one of the repair filament and the connecting filament can extend through at least a portion of the axial bore, and the bore can be sized such that a portion of the filament extending therethrough barely fits to help maintain the connection between the anchor, repair filament, and connecting filament. Embodiments of the systems and devices disclosed can be used in a number of methods for repairing soft tissue.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of and claims priority to U.S.patent application Ser. No. 15/692,885, filed Aug. 31, 2017, andentitled “Systems, Devices, and Methods for Securing Tissue Using HardAnchors,” which is a continuation of and claims priority to U.S. patentapplication Ser. No. 13/623,429, filed Sep. 20, 2012, and entitled“Systems, Devices, and Methods for Securing Tissue Using Hard Anchors,”and which issued as U.S. Pat. No. 9,763,655 on Sep. 19, 2017, thecontents of each which is hereby incorporated by reference herein intheir entireties.

FIELD

The present disclosure relates to systems, devices, and methods forsecuring soft tissue to bone, and more particularly relates to securingsoft tissue using rigid or hard anchors in conjunction with acombination of surgical filaments to minimize trauma during surgicalprocedures.

BACKGROUND

A common injury, especially among athletes and people of advancing age,is the complete or partial detachment of tendons, ligaments, or othersoft tissues from bone. Tissue detachment may occur during a fall, byoverexertion, or for a variety of other reasons. Surgical interventionis often needed, particularly when tissue is completely detached fromits associated bone. Currently available devices for tissue attachmentinclude screws, staples, suture anchors, and tacks. Currently availabledevices for patients of advancing age can be particularly insufficientdue to soft and weak bones leading to inadequate fixation between theanchor and bones and the anchors and filaments with which the anchorsare coupled.

Anchors and repair filaments are typically used in soft tissue repairprocedures to secure the tissue in a desired location. Smaller anchorscan be helpful in minimizing trauma associated with creating surgicalopenings for accessing the location for soft tissue repair, and forminimizing trauma associated with implanting the anchor in bone as partof the tissue repair procedure. Because anchors are often disposed inholes that are pre-formed in bone, the smaller an anchor is, the smallera pre-formed hole can be. The anchors can include repair filamentscoupled thereto and the repair filaments can be coupled to the softtissue and operable to draw the soft tissue closer to the bone in whichthe anchor is implanted. A number of challenges, however, presentthemselves when using small anchors coupled with repair filaments forsoft tissue repair. For example, despite their size, small anchors andrepair filaments are limited in their abilities to withstand both highlevels of load that result from tissue and bone movement after theprocedure is completed and high levels of load that can occur while theprocedure is being performed. Additionally, the small anchors and repairfilaments can be susceptible to undesirably sliding therebetween bothduring and after the procedure. Likewise, the repair filaments can besusceptible to undesirably fraying or breaking, for instance atlocations where the repair filament is coupled to the anchor.

It can also be desirable to minimize the number of knots used inconjunction with the repair filament when performing soft tissue repairprocedures. A variety of different knots, such as sliding knots, can beused to help draw and secure soft tissue with respect to bone. Althoughthe tying of knots at a surgical site is common, in some instances knotscan have a tendency to slip, which in turn can cause a loss of tensionbetween the tissue and bone. This drawback is sometimes referred to as aloss of “loop security.” In addition to this “loop security” issue,conventional knots typically have an overall size that can beobstructive or intrusive, especially in tight joints, which may damagecartilage or other tissue by abrasion with the knot.

It is therefore desirable to provide systems, devices, and methods thatreduce the amount of trauma associated with using hard or rigid anchorsduring soft tissue repair procedures while maintaining or improving theholding strength such systems, devices, and methods can provide. It isalso desirable to provide systems, devices, and methods for use in softtissue repair that minimize or eliminate the number and size of knots tobe tied by a surgeon, particularly during arthroscopic repairprocedures.

SUMMARY

Systems, devices, and methods are generally provided for securing softtissue to bone. In one exemplary embodiment a surgical soft tissuerepair device includes an anchor, a repair filament, and a connectingfilament in sliding engagement with the repair filament. The anchor canbe configured to be fixated in bone and can have at least one boreextending therethrough. The connecting filament can have a foldedconfiguration in which the connecting filament is unable to pass throughthe bore and can be effective to connect the repair filament to theanchor. In some embodiments the anchor can be a rigid anchor. Further,in some embodiments the repair filament can include a snare assemblyhaving a collapsible snare at one end and a terminal end opposite thecollapsible snare. The anchor can be positioned at an intermediatelocation on the repair filament between the collapsible snare and theterminal end.

The bore of the anchor can be an axial bore, or alternatively, it can bea transverse bore. In an embodiment in which the bore is an axial bore,the bore can be stepped such that there is a first, smaller diameter ata proximal end of the bore and a second, greater diameter at a distalend of the bore. The connecting filament can include at least one of acontinuous loop and a knot. In some embodiments the repair filament canslidably engage with the connecting filament by passing through theconnecting filament. In some other embodiments the connecting filamentcan be held by the anchor and/or an insertion tool. In still otherembodiments the connecting filament does not couple to the anchor. Theconnecting filament can have a first configuration in which it is ableto pass through the bore of the anchor and a second configuration inwhich it is unable to pass through the bore of the anchor, thereby beingeffective to secure the repair filament to the anchor. An insertion toolcan be removably coupled to the anchor. The insertion tool can have atleast one bore extending therethrough with its bore being substantiallyaligned with the bore of the anchor.

One exemplary embodiment of a surgical repair method includes insertingan anchor into a hole in a bone at a location proximate to detached softtissue. The anchor can have a bore extending therethrough and the anchorcan be coupled to a snare assembly by a connecting filament that isdisposed in or adjacent to the bore at a position distal to the snareassembly. The snare assembly can have a collapsible snare at one end andat least one elongate filament extending therefrom. The elongatefilament can have a terminal end opposite the collapsible snare. Themethod can also include passing at least one of the snare and theterminal end of the elongate filament through at least a portion of thedetached tissue, inserting the terminal end of the elongate filamentthrough the snare, collapsing the snare around the elongate filament,and sliding the collapsed snare toward the soft tissue to apply tensionto the filament between the anchor and the tissue to bring the tissueinto proximity with the bone. The connecting filament can be slidablycoupled to the repair filament approximately at or adjacent to a distalend of the anchor. In some embodiments, the method can further includeactuating the connecting filament to move from a first configuration inwhich it is able to pass through the bore of the anchor to a secondconfiguration in which it is unable to pass through the bore of theanchor and is effective to secure the repair filament to the anchor.

In some embodiments at least a portion of the connecting filament can bedisposed within the bore. In some other embodiments at least a portionof the repair filament can be disposed within the bore and theconnecting filament can be disposed on a side of the bore opposite tothe snare assembly. The method can also include tensioning the repairfilament to configure the connecting filament in a connectingconfiguration in which the connecting filament is unable to pass throughthe bore to fix tissue relative to the bone.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a schematic view of one exemplary embodiment of a surgicalsoft tissue repair device;

FIG. 2A is a schematic view of another exemplary embodiment of asurgical soft tissue repair device;

FIG. 2B is a schematic view of still another exemplary embodiment of asurgical soft tissue repair device;

FIG. 3 is a schematic view of one exemplary embodiment of a snareassembly for use as a repair filament of a surgical soft tissue repairdevice;

FIG. 4A is a schematic view of a snare assembly having a noose formedtherein with first and second filament limbs extending to a second end;

FIGS. 4B and 4C are sequential views of the snare assembly of FIG. 4Awith the first and second filament limbs passed through the noose toform a snare or cinch noose;

FIGS. 5A-5D are sequential views of another exemplary embodiment forforming a snare assembly having a snare at a first end and first andsecond filament limbs extending to a second end;

FIG. 6A is a schematic view of one exemplary embodiment of a surgicalsoft tissue repair device that includes an anchor, a repair filament,and one exemplary embodiment of a connecting filament configuration forcoupling the repair filament to the anchor;

FIG. 6B is a schematic view of the surgical soft tissue repair device ofFIG. 6A disposed in bone;

FIG. 7A is a schematic view of another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and another exemplary embodiment of a connecting filamentconfiguration for coupling the repair filament to the anchor;

FIG. 7B is a schematic view of the surgical soft tissue repair device ofFIG. 7A disposed in bone;

FIG. 8A is a schematic view of still another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and still another exemplary embodiment of a connectingfilament configuration for coupling the repair filament to the anchor;

FIG. 8B is a schematic view of the surgical soft tissue repair device ofFIG. 8A disposed in bone;

FIG. 9A is a schematic view of yet another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and yet another exemplary embodiment of a connecting filamentconfiguration for coupling the repair filament to the anchor;

FIG. 9B is a schematic view of the surgical soft tissue repair device ofFIG. 9A disposed in bone;

FIG. 10A is a schematic view of another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and another exemplary embodiment of a connecting filamentconfiguration for coupling the repair filament to the anchor;

FIG. 10B is a schematic view of the surgical soft tissue repair deviceof FIG. 10A disposed in bone;

FIG. 11A is a schematic view of still another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and still another exemplary embodiment of a connectingfilament configuration for coupling the repair filament to the anchor;

FIG. 11B is a schematic view of the surgical soft tissue repair deviceof FIG. 11A disposed in bone;

FIG. 12A is a schematic view of yet another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and yet another exemplary embodiment of a connecting filamentconfiguration for coupling the repair filament to the anchor;

FIG. 12B is a schematic view of the surgical soft tissue repair deviceof FIG. 12A disposed in bone;

FIG. 13A is a schematic view of another exemplary embodiment of asurgical soft tissue repair device that includes an anchor, a repairfilament, and another exemplary embodiment of a connecting filamentconfiguration for coupling the repair filament to the anchor;

FIG. 13B is a schematic view of the surgical soft tissue repair deviceof FIG. 13A disposed in bone;

FIGS. 14A-14G are sequential views of one exemplary embodiment for usingthe surgical soft tissue repair device of FIG. 1 to secure tissue tobone;

FIGS. 15A-15G are sequential views of one exemplary embodiment for usingthe surgical soft tissue repair device of FIG. 2A to secure tissue tobone;

FIG. 16 is a schematic view of still another exemplary embodiment of asurgical soft tissue repair device;

FIG. 17 is a schematic view of the surgical soft tissue repair device ofFIG. 16 coupled to an insertion tool;

FIG. 18 is a schematic view of an insertion assembly that includes thesurgical soft tissue repair device and insertion tool of FIG. 17, aswell as a guide portion and spacer element; and

FIGS. 19A-19E are sequential views of one exemplary embodiment for usingthe insertion assembly of FIG. 18 to secure tissue to bone.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention. Further, in the present disclosure,like-numbered components of the embodiments generally have similarfeatures. Additionally, to the extent that linear or circular dimensionsare used in the description of the disclosed systems, devices, andmethods, such dimensions are not intended to limit the types of shapesthat can be used in conjunction with such systems, devices, and methods.A person skilled in the art will recognize that an equivalent to suchlinear and circular dimensions can easily be determined for anygeometric shape. Sizes and shapes of the systems and devices, and thecomponents thereof, can depend at least on the anatomy of the subject inwhich the systems and devices will be used, the size and shape ofcomponents with which the systems and devices will be used, and themethods and procedures in which the systems and devices will be used.

The figures provided herein are not necessarily to scale. Still further,to the extent arrows are used to describe a direction of movement, thesearrows are illustrative and in no way limit the direction the respectivecomponent can or should be moved. A person skilled in the art willrecognize other ways and directions for creating the desired result.Additionally, a number of terms may be used throughout the disclosureinterchangeably but will be understood by a person skilled in the art.By way of non-limiting example, the terms suture, filament, and flexiblemembers may be used interchangeably.

Systems, devices, and methods for soft tissue repair are generallyprovided and they generally involve the use of surgical filaments and/orflexible members in conjunction with hard or rigid anchors. Surgicalrepair filaments, which are flexible members that can come in a varietyof configurations, are used in connection with anchors to attach orreattach soft tissue to bone. The repair filaments can pass through softtissue so that the soft tissue can be positioned in a desired location.The repair filaments are secured to anchors which, in turn, are fixed inbone. In one aspect of the invention, the anchors have one or morelumens or bores extending therethrough for receiving all or part of therepair filament. In a further aspect, the lumens or bores of the anchorhave a diameter that is slightly larger than a width formed by a repairfilament such that the lumen or bore is barely able to accommodate therepair filament. In some embodiments the width formed by the repairfilament can be the equivalent of a diameter of the repair filament,while in some other embodiments the width formed by the repair filamentcan be the equivalent of approximately two diameters of the repairfilament, for instance when at least a portion of a loop of repairfilament is disposed in the lumen or bore of the anchor. A configurationin which the lumen or bore of the anchor is barely able to accommodatethe repair filament can allow the repair filament to slide with respectto the anchor while still preventing the repair filament from easilyfalling out of the bore or lumen.

The repair filament can interface with the anchor and connect theretowith the aid of a connecting filament. In some embodiments, the repairfilament and the connecting filament can be in sliding engagementapproximately at or adjacent to a distal end of the anchor. Theconnecting filament is such that it has a diameter, either in a normalconfiguration or an altered configuration, that is greater than thediameter of the lumen or bore. When the connecting filament is in analtered configuration, such as a folded configuration, the connectingfilament can be unable to pass through the bore. The connecting filamentcan render a rigid engagement member, such as a cross-bar or eyelet,unnecessary. Further, the repair filament is able to couple to theconnecting filament in such a way that provides a secure connectionbetween the repair filament, the anchor, and soft tissue that is to berepaired or reattached. While in some embodiments at least a portion ofthe repair filament can extend substantially through the bore, in otherembodiments a portion of the connecting filament extends proximallythrough the bore of the anchor and couples with the repair filament at aproximal side of the anchor. In such embodiments, the lumens or bores ofthe anchor have a diameter that is slightly larger than a width formedby a connecting filament such that the lumen or bore is barely able toaccommodate the connecting filament. This configuration prevents theconnecting filament from easily falling out of the bore or lumen whilestill allowing the repair filament to slide with respect to the anchor.

One beneficial aspect of the devices and systems described herein isthat the use of relatively small anchor devices is possible, whilemaintaining the ability to use a high strength repair filament andanchor system that can withstand high loads. The use of a soft andflexible connecting filament is also advantageous in that it enables theuse of smaller anchors and provides for an interface between the anchorand repair filament that reduces trauma to the patients as well as therisk of damage to the repair filament. Further, the repair filament isable to slide relative to the connecting filament without damagingeither component and while minimizing the risk of undesirable slippagebetween the repair filament and the anchor, and in turn between the softtissue and bone attached thereto. The devices and systems providedherein allow for both improved and new procedures for soft tissuerepair, and can be used in a number of different types of surgicalprocedures, including by way of non-limiting examples rotator cuff andinstability repair procedures and other types of tendon and tissuerepair procedures.

Soft Tissue Repair Devices

FIGS. 1, 2A, and 2B illustrate exemplary embodiments of surgical softtissue repair devices that can be used to perform soft tissue repairs.Each includes a hard or rigid anchor for implantation into bone, arepair filament for coupling to soft tissue and drawing the soft tissuetoward the bone in which the anchor is implanted, and a connectingfilament for associating the repair filament with the anchor. Using softand flexible components like a connecting filament in conjunction withrepair filaments and hard anchors can be beneficial at least because itprovides for a strong fixation in bone with additional flexibility inthe design while minimizing the risk of trauma to the patient and damageto the repair filament.

FIG. 1 illustrates one exemplary embodiment of a surgical soft tissuerepair device 310 that includes a hard or rigid anchor 312, a repairfilament 320, and a connecting filament 317 that couples the repairfilament 320 to the anchor 312. As shown, the anchor 312 includes anaxial bore 316 formed therethrough and the connecting filament 317 isdisposed through the bore 316 and is configured to couple to the repairfilament 320 such that the anchor 312 is at an intermediate location onthe repair filament 320. While the anchor and any associated bores andlumens can have a variety of configurations, in the illustratedembodiment the bore 316 is stepped such that a distal end 316 d of thebore 316 has a diameter that is greater than a more proximal portion 316p of the bore 316. In other embodiments the bore 316 can have a constantdiameter. In the illustrated embodiment the diameter of the proximalportion 316 p is sized such that it is slightly larger than a widthformed by the connecting filament 317 such that the bore 316 is barelyable to accommodate the connecting filament 317. As shown, the widthformed by the connecting filament 317 is approximately two diameters ofthe filament 317 due to the filament 317 having a looped configurationwithin the bore 316.

The repair filament can have a variety of configurations andconstructions, including as simple as being an elongate flexible memberor suture filament. However, in one embodiment the repair filament 320can be a snare assembly having a collapsible snare 330 formed on a firstend 322 and a terminal end 324 opposite the first end 322, with anintermediate portion extending therebetween. In some embodiments asleeve 350 can be disposed around at least a portion of the repairfilament 320. The terminal end 324 can be configured to pass through anopening 332 in the snare 330 to create a tensionable construct so thatthe snare assembly can draw two or more objects, such as tissue andbone, closer together, as described in greater detail below with respectto FIGS. 14A-15G.

The connecting filament 317 can be effective to connect the repairfilament 320 and the anchor 312 in a way that minimizes the potentialfor damage to the repair filaments. As shown, a distal end 317 d of theconnecting filament 317 can be configured to have a diameter that isgreater than the diameter of the bore 316, either in its natural stateor in certain anchoring configurations that can result, for instance,from actuation initiated by a surgeon. In some embodiments the diameterof the distal end 317 d of the connecting filament 317 remainsapproximately constant and it has dimensions that prevent its passageproximal of the distal end 316 d of the bore 316. In other embodimentsthe distal end 317 d can be actuated (e.g., by tension) to transitionfrom an unstressed configuration in which the connecting filament 317could fully pass through the bore 316 and an anchoring configuration inwhich the diameter of the connecting filament 317 increases to a sizethat prevents its passage through the bore 316. Accordingly, theconnecting filament 317 is configured or configurable to be unable topass through the bore 316. A person skilled in the art will recognizeconfigurations of a connecting filament that can be used to allow aconnecting filament to move from a first, unstressed configuration to asecond, anchoring configuration. Some non-limiting examples of filamentsthat can move between these two configurations and which can be adaptedfor use as a connecting filament in conjunction with the teachingsherein are described in greater detail in U.S. patent application Ser.No. 13/465,376 filed May 7, 2012, and entitled “Systems, Devices, andMethods for Securing Tissue Using Snare Assemblies and Soft Anchors,”the content of which is incorporated by reference herein in itsentirety. A proximal end 31′7 p of the connecting filament 317 can beconfigured to couple to the repair filament 320, which in theillustrated embodiment is accomplished by looping the repair filament320 through a loop in the proximal end 317 p of the connecting filament317. A person skilled in the art will recognize a number of differentways by which the repair filament 320 can be coupled to the connectingfilament 317, including by passing one filament through the other.

FIG. 2A illustrates another exemplary embodiment of a surgical softtissue repair device 410 in which a repair filament 420 is a snareassembly similar to the snare assembly of FIG. 1 in that it includes acollapsible snare 430 formed on a first end 422, a terminal end 424opposite the first end 422, the terminal end 424 being configured topass through an opening 432 in the snare 430 to create a tensionableconstruct, and an optional sleeve 450 disposed around at least a portionof the repair filament 420. The repair filament 420 is coupled to thehard anchor 412 by way of a flexible connecting filament 417 disposed ona distal side 412 d of the anchor 412 such that the anchor 412 is at anintermediate location on the repair filament 420. As shown, theconnecting filament 417 is in sliding engagement with the repairfilament 420 approximately at or adjacent to the distal end 412 d of theanchor 412. FIG. 2B illustrates an exemplary embodiment of a surgicalsoft tissue repair device 410′ that is similar to the surgical repairdevice 410 of FIG. 2A except the repair filament 420′ is not a snareassembly but is instead an elongate filament having proximal and distalends. The repair filament 420′ is coupled to a hard anchor 412′ having aflexible connecting filament 417′ associated therewith at a distal end412 d′ thereof such that the anchor 412′ is at an intermediate locationon the repair filament 420′. As shown, the connecting filament 417′ isin sliding engagement with the repair filament 420′ approximately at oradjacent to the distal end 412 d′ of the anchor 412′. The repairfilament 420′ can be slidably coupled to the flexible connectingfilament 417′ such that it can move distally approximately in adirection K and proximally approximately in a direction L as illustratedby the arrows in FIG. 2B. Although FIGS. 2A and 2B illustrate theengagement between the repair filament 420, 420′ and the connectingfilament 417, 417′ to be approximately at or distal to the distal end412 d, 412 d′ of the anchor 412, 412′, it is understood that tensionapplied to the repair filament 420, 420′ can cause the location of theengagement between the two filaments to shift proximally to a positionslightly adjacent to the distal end 412 d, 412 d′.

The anchor 412, 412′ can include an axial bore 416, 416′ formedtherethrough and the repair filament 420, 420′ can be disposed throughthe bore 416, 416′ to couple to the connecting filament 417, 417′. Theconnecting filament 417, 417′ can be effective to connect the repairfilament 420, 420′ and the anchor 412, 412′. As shown, the connectingfilament 417, 417′ can be configured such that in an approximatelyfolded configuration the connecting filament 417, 417′ is unable to passthrough the bore 416, 416′ because a width formed when two portions ofthe connecting filament 417, 417′ are compressed together is greaterthan the diameter of the bore 416, 416′, thus anchoring the repairfilament 420, 420′ with respect to the anchor 412, 412′. The diameter ofthe bore 416, 416′ is sized such that it is slightly larger than thewidth formed by the repair filament 420, 420′ such that the bore 416,416′ is barely able to accommodate the repair filament 420, 420′. In theillustrated embodiments, the width formed by the repair filament 420,420′ is approximately two diameters of the filament 420, 420′ due to twoportions of the filament 420, 420′ being disposed in the bore 416, 416′.A person having skill in the art will understand that a location of theconnecting filament 417, 417′ can also be maintained by load applied bythe repair filament 420, 420′ and/or using one or more insertion tools,as described below.

The repair filament 420, 420′ can couple to the connecting filament 417,417′ in a variety of manners. As shown, the connecting filament 417,417′ is disposed at the distal side 412 d, 412 d′ of the anchor 412,412′ and the repair filament 420, 420′ passes through and exits theaxial bore 416, 416′ and is coupled to the connecting filament 417, 417′by passing the repair filament 420, 420′ around the connecting filament417, 417′. The relatively small diameter of the bore 416, 416′, which isbarely wide enough to accommodate the repair filament 420, 420′,contributes to the stability of the coupling between the repair filament420, 420′ and the connecting filament 417, 417′. For example, the systemas shown in FIGS. 2A and 2B is able to remain intact due to the relativedimensions of the bore 416, 416′, the repair filament 420, 420′, and theconnecting filament 417, 417′. Other known filament connectingtechniques can also be used, including tying one or more knots to secureone filament to the other or passing one filament through the other. Insome embodiments the repair filament 420, 420′ may be coupled to theconnecting filament 417, 417′ before the device 410, 410′ is packaged,while in other embodiments the repair filament 420, 420′ may be coupledto the connecting filament 417, 417′ by a surgeon after the device 410,410′ is removed from a package and prior to implantation.

The connecting filaments 417, 417′ of FIGS. 2A and 2B can also have avariety of configurations to assist in coupling the repair filaments420, 420′ to the anchors 412, 412′, respectively. Although in theillustrated embodiments the connecting filaments 417, 417′ rely on anapproximately folded configuration to prevent the connecting filaments417, 417′ from passing through the bores 416, 416′, they can have adiameter that prevents them from passing through the bore 416, 416′.Further exemplary configurations are also described in greater detailbelow with respect to FIGS. 6A-13B and 16.

Anchors

Suture anchors for use in the repair devices provided herein can have avariety of configurations. The embodiments of FIGS. 1 and 2A and 2Billustrate some examples of anchors 312, 412, 412′ that can be used inconjunction with the disclosures herein. In each embodiment the anchor312, 412, 412′ is generally elongate, cylindrical, and small, and issized to fit in a pre-drilled bore formed in bone. The anchors 312, 412,412′ can include bone-engaging surface features, such as teeth, ridges,or, as shown, outer threads, to assist in securing a location of theanchors 312, 412, 412′ within the pre-drilled bore, and the anchors 312,412, 412′ can each include their own bores 316, 416, 416′ extendingtherethrough. Commercially available hard anchors, such as anchors inthe Healix family and the Gryphon family from DePuy Mitek, Inc., can beused and/or modified by a person skilled in the art for use inconjunction with the disclosures herein. Further, soft anchors can alsobe used in conjunction with the repair filaments and connectingfilaments described herein, including but not limited to soft anchorsdescribed in U.S. patent application Ser. No. 13/465,376 filed May 7,2012, and entitled “Systems, Devices, and Methods for Securing TissueUsing Snare Assemblies and Soft Anchors,” the content of which wasalready incorporated by reference herein in its entirety.

A size and shape of the anchor, as well as the materials from which theanchor is constructed, can depend, at least in part, on the sizes,shapes, and materials with which the anchor is used, including thesizes, shapes, and materials of the repair and connecting filaments, theobstructions through which it may pass, as well as on the type ofprocedure being performed. In some embodiments the anchor can have adiameter in the range of about 1 millimeter to about 12 millimeters, andin one embodiment the diameter can be about 2 millimeters, and a lengthin the range of about 5 millimeters to about 24 millimeters, and in oneembodiment the length can be about 10 millimeters. Examples of exemplarymaterials that can be used to form the anchor include but are notlimited to bioabsorbable elastomers, copolymer combinations such aspolylactic acid-polyglycolic acid (PLA-PGA), and bioabsorbable polymerssuch as aliphatic polyesters, poly(amino acids), copoly(ether-esters),polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates,poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters,polyoxaesters containing amine groups, poly(anhydrides),polyphosphazenes, biomolecules (i.e., biopolymers such as collagen,elastin, bioabsorbable starches, etc.) and blends thereof In someembodiments, the suture anchors can be formed from polylactic acid, or acomposite blend of tricalcium phosphate and polylactic acid. The sutureanchors disclosed herein can also be formed from non-absorbablematerials, such as polyether ether ketone (PEEK) and polysulfone, ormetals such as titanium.

Likewise, the size of the bore can depend, at least in part, on thesizes, shapes, and materials with which the anchor is used, includingthe sizes, shapes, and materials of the repair and connecting filaments,as well as on the type of procedure being performed. Generally, adiameter of the bore is slightly larger than a width formed by a repairfilament or a connecting filament passing therethrough such that thelumen or bore is barely able to accommodate the respective filament. Insome embodiments the width formed by the repair or connecting filamentthat passes through the lumen or bore of the anchor can be approximatelythe same as a diameter of the filament, while in some other embodiments,such as those illustrated in FIGS. 1 and 2A and 2B, the width formed bythe repair or connecting filament that passes through the lumen or boreof the anchor can be about the size of two diameters of the filament.Such a configuration allows for the filament passing through the lumenor bore of the anchor to remain substantially associated with the anchoreven when tension is not applied to the repair filament or connectingfilament to keep the repair filament and connecting filament near theanchor. In some exemplary embodiments a diameter of the bore is in therange of about 0.2 millimeters to about 4 millimeters, and in oneembodiment the diameter of the bore can be about 0.5 millimeters.Further, although in the illustrated embodiments the anchors include anaxial bore, in some embodiments the anchor can include a transverse borein lieu of or in addition to an axial bore. Other variations on theanchor configurations that are known to those skilled in the art canalso be accommodated.

Repair Filaments

As noted above, virtually any repair filament can be used with therepair systems described herein. A person skilled in the art will beable to choose a repair filament having an appropriate size and made ofan appropriate material that is suitable for use in any given procedure.

FIG. 3 illustrates one exemplary embodiment of a repair filament for usein conjunction with various anchors and connecting filaments. In theillustrated embodiment of FIG. 3 the repair filament is a snare assembly20. As shown in FIG. 3, the snare assembly 20 can generally be flexible,can include a snare 30 formed on a first end 22, and can have a terminalend 24 opposite the first end 22, with an intermediate portion extendingtherebetween. The terminal end 24 can be configured to pass through anopening 32 in the snare to create a tensionable construct so the snareassembly can draw two or more objects, such as tissue and bone, closertogether. Further, the snare assembly 20 can also be used as atensioning member to help move a connecting filament against an anchorto generally secure a location of the snare assembly 20 with respect tothe anchor. In some embodiments the snare assembly 20 can be used tohelp secure a location of an anchor within bone, for instance byapplying tension to the snare assembly 20 to set the position of theanchor in bone, as known to those skilled in the art. Exemplary anchorsfor such embodiments include, but are not limited to, toggle-typeanchors.

Optionally, a flexible sleeve 50 can be provided for encapsulating atleast a portion of the snare assembly 20. As shown in FIG. 3, the sleeveencapsulates a portion of the assembly 20 starting at the terminal end24 and extending toward the first end 22. In other embodiments thesleeve can extend more proximal than the terminal end 24. Aconfiguration of this nature can aid a surgeon in pulling the snareassembly 20 through a portion of the body by providing extra length ontowhich he or she can grasp. Preferably, once the assembly 20 isimplanted, the sleeve 50 can extend outside of a body as well as outsideof a cannula placed in the body. This can allow the sleeve 50 to be usedby a surgeon during a surgical procedure, and it can also be easilyremoved once it is no longer being used by the surgeon. The sleeve 50can have a generally cylindrical configuration and can be flexible toallow it to bend as shown in various embodiments provided herein. Thesleeve 50 can be useful when passing the assembly 20 throughobstructions such as an anchor and/or tissue for a number of reasons.The sleeve 50 can be configured to have a smoother surface that isbetter configured to pass through tissue, thus reducing the possibilityof fraying the filament of the snare assembly 20 or causing trauma tothe tissue. Still further, because the sleeve 50 can encapsulate aplurality of filament limbs, the sleeve 50 can ease filament managementby maintaining the filaments within the enclosed sleeve 50. The sleeve50 can be removable, and thus it can be removed at any time during theprocedure, or at the conclusion of the procedure.

FIGS. 4A-4C illustrate one exemplary method of forming a snare assembly.As shown in FIG. 4A, the snare assembly 120 can be a filament having anoose 160 and noose limbs 164, 166. The noose 160 defines a centralopening 162 and secondary openings 161 and 163 formed from a half hitchplus one additional throw of limb 166 through central opening 162. Aflexible sleeve 150 is shown in phantom as it optionally encapsulates aportion of limbs 164 and 166 in certain constructions, as described inmore detail below.

FIGS. 4B and 4C more particularly illustrate the formation of a cinchnoose or snare 130 in an improved cinch noose construct or snareassembly 120, having an opening 132. The ends of free filament limbs 134and 136 of the filament are passed through central opening 162, asrepresented by arrows 137 and 139 in FIG. 4B, which draws noose limbs134 and 136 therethrough. Noose 160 is then tightened, as shown in FIG.4C, to form a slidable knot for the snare 130. Alternatively, if asleeve 150, as shown in FIG. 4A, or a sleeve 150′, as shown in FIG. 4C,is not utilized, or if such sleeve is removed after being passed throughtissue to be tensioned, then one or both of free limbs 134, 136 can bepassed through one or both of the openings 161, 163.

Joining together at least the free filament limbs improves suturemanagement and reduces the possibility of suture entanglement or damageby instruments, especially when passed through a cannula. For example, asurgeon or other user need only grasp and pass one sleeve 150 throughthe noose 160 to thereby manipulate the free filament limbs 134, 136 asa single unit.

FIGS. 5A-5D illustrate another exemplary method of forming a snareassembly 220 having a snare 230 and a coaxial sliding neck 235 for usein a surgical repair construct. In this exemplary embodiment, the snare230 is formed from a bifurcated suture filament having a tubular portion237 with a core removed therefrom to form a cannulated portion 239 andfirst and second terminal limbs 234, 236. As shown in FIG. 5B, theterminal limbs 234, 236 can be curled back toward the tubular portion237 to form a loop having an opening 232 that defines the snare 230. Asshown in FIG. 5C, a bore 260 can be formed on a side of the tubularportion 237 and the terminal limbs 234, 236 can be placed into thecannulated tubular portion 239 through the bore 260. Ends of theterminal limbs 234, 236 can be fed through the cannulated portion 239,and as shown in FIG. 5D, the terminal limbs 234, 236 can be pulleddistally (direction A in FIG. 5D) through the tubular portion 237 suchthat the tubular portion 237 is fed through itself. Accordingly, thesnare 230 can be collapsed by tensioning the limbs 234, 236 and/orcoaxial sliding neck 235 in approximately a first direction A, and thesnare 230 can be expanded by applying a force to the snare 230 inapproximately a second, opposite direction B, which pulls the limbs 234,236 towards the snare 230. Passing the filament through itself to form acoaxial sliding neck allows the filament to have a low profile thatminimizes the amount of space the construct consumes in the body andthat minimizes and/or eliminates trauma associated with passing thefilament through tissue.

A person skilled in the art will recognize a number of other ways that asnare for use in snare assemblies can be created and used in conjunctionwith the teachings herein. For example, a number of different slidingknots can be used to form snares, including but not limited to aBuntline Hitch, a Tennessee Slider, a Duncan Loop, a Hangman's Noose,and a coaxial sliding neck. To the extent the sliding knot used to forma snare affects the operation of the snare, for instance whether a limbis pulled through a knot to change the position of the knot or a knot isslid along a limb to change the position of the knot, a person skilledin the art would be able to adapt these types of knots for use with theteachings of the present invention without departing from the spirit ofthe present disclosure. As described herein, unless otherwisedesignated, a knot used to form a snare is movable away from theterminal end of the snare assembly to collapse the snare and towards theterminal end to increase a size of the snare.

The snare assemblies 20, 120, 220 can be made of any suitable flexiblematerial, for instance a filament, including a cannulated filament, abraided filament, and a mono filament. The type, size, and strength ofthe flexible material can depend, at least in part, on the type ofanchor with which it is used, any obstructions through which the snareassembly may pass, and the type of procedure in which it is used. In oneexemplary embodiment the flexible material is an Orthocord™ filamentthat is commercially available from DePuy Mitek, Inc or Ethibond™filament available from Ethicon, Inc. Generally the filament isrelatively thin to minimize any trauma to tissue through which itpasses. In some embodiments the filament can have a size between about a#5 filament (about 20 gauge to about 21 gauge) and about a #5-0 filament(about 35 gauge to about 38 gauge). The Orthocord™ or Ethibond™ filamentcan be useful because it has a braided configuration, which allows othercomponents, including the filament itself, to pass through subcomponentsof the braid without causing damage to the filament. Filamentsconfigured to allow for a cannulated configuration, such as by removinga core therefrom or having a pre-formed cannulated configuration, canalso be used. Orthocord™ suture is approximately fifty-five tosixty-five percent PDS™ polydioxanone, which is bioabsorbable, and theremaining thirty-five to forty-five percent ultra high molecular weightpolyethylene, while Ethibond™ suture is primarily high strengthpolyester. The amount and type of bioabsorbable material, if any,utilized in the filaments of the present disclosure is primarily amatter of surgeon preference for the particular surgical procedure to beperformed. Further, a length of filaments used to form the snareassemblies 20, 120, 220 can be in the range of about 15 centimeters toabout 125 centimeters, and in one embodiment it can be about 60centimeters.

A person skilled in the art will recognize that the configurations ofFIGS. 3-5D are just some options for forming repair filaments such assnare assemblies. In other embodiments the repair filament can simply bea filament having proximal and distal ends and configured to slide withrespect to a rigid or hard anchor, such as the repair filament 420′ ofFIG. 2B. In one exemplary embodiment the repair filament 420′ is a #3-0filament (about 29 gauge to about 32 gauge), such as an Orthocord™filament that is commercially available from DePuy Mitek, Inc orEthibond™ filament available from Ethicon, Inc. Generally the filamentis relatively thin to minimize any trauma to tissue through which itpasses. In some embodiments the filament can have a size between about a#5 filament (about 20 gauge to about 21 gauge) and about a #5-0 filament(about 35 gauge to about 38 gauge). Other exemplary embodiments ofrepair filaments that can be used in conjunction with the teachingsherein are described at least in U.S. patent application Ser. No.13/465,288 filed May 7, 2012, and entitled “Systems, Devices, andMethods for Securing Tissue,” U.S. patent application Ser. No.13/218,810 filed Aug. 26, 2011, and entitled “Surgical Filament SnareAssemblies,” and U.S. patent application Ser. No. 13/465,362 filed May7, 2012, and entitled “Systems, Devices, and Methods for Securing TissueUsing a Suture Having One or More Protrusions,” the content of which arealso incorporated by reference herein in their entireties.

Connecting Filaments

One or more connecting filaments can be used to assist in coupling oneor more repair filaments to one or more anchors, thereby making rigidengagement members such as cross-bars or eyelets, unnecessary. FIGS.6A-13B illustrate a variety of configurations of a connecting filamentfor such use. In each instance the connecting filament is coupled to therepair filament approximately at or adjacent to a distal end of theanchor and the connecting filament is configured in a manner thatprevents the connecting filament from passing through an axial bore ofthe anchor. This configuration can generally be referred to as analtered configuration or a folded configuration. As a result, the repairfilament can remain coupled to the anchor and can then be used to repairsoft tissue by coupling the repair filament with the soft tissue andthen using the repair filament to draw the soft tissue toward the anchorand bone in which the anchor is disposed. Further, the embodiments ofFIGS. 6A-13B provide for configurations that help maintain a location ofthe connecting filament with respect to the anchor so that theconnecting filament does not move out of place accidentally.

FIGS. 6A and 6B illustrate one exemplary embodiment of a surgical softtissue repair device 510 that includes a hard anchor 512 having an axialbore 516 formed therethrough, a repair filament 520, and a connectingfilament 517. As shown, the connecting filament 517 can be a continuousloop and the repair filament 520 can pass through a center 518 of thecontinuous loop approximately at or adjacent to a distal end 512 d ofthe anchor 512. The diameter of the connecting filament 517 can be largeenough such that even when the continuous loop is flexible and iscompressed so that a left side of the loop contacts a right side of theloop, the resulting folded width of the connecting filament 517 canstill be larger than the diameter of the axial bore 516 so that theconnecting filament 517 does not pass through the bore 516 when tensionis applied to the repair filament 520 approximately in a direction T,which can occur during and after a surgical procedure. As shown in FIG.6B, the device 510 can be implanted in a bore 1002 formed in bone 1001.Because a diameter of the bore 516 is generally the same size as or onlyslightly larger than a width formed by the repair filament 520, therepair filament 520 does not generally fall out of the bore 516. Therepair suture can also be kept in place by an insertion tool assembly,as discussed in greater detail below. Further, as illustrated in FIG.6B, because there is generally a relatively small distance between thedistal end 512 d of the anchor 512 and the bottom of the bore 1002 intowhich the anchor 512 is inserted, e.g., in the range of about 1millimeter to about 15 millimeters, the repair filament 520 can remainnear the anchor 512 for use in a procedure even if the repair filament520 were to fall distally away from the anchor 512.

FIGS. 7A and 7B illustrate another exemplary embodiment of a surgicalsoft tissue repair device 610 that includes a hard anchor 612 having anaxial bore 616 formed therethrough, a repair filament 620, and aconnecting filament 617. As shown, the connecting filament 617 can be aknotted construction forming a continuous loop and the repair filament620 can pass through a loop 618 formed by the knotted constructionapproximately at or adjacent to a distal end 612 d of the anchor 612.One or more knots 619 can be formed in the connecting filament 617 usingtechniques known to those skilled in the art, including techniquesdescribed in other patent applications incorporated by reference herein.The knots 619 can be pre-formed so that a surgeon does not need to tiethe knots during a surgical procedure, although a surgeon can choose totie one or more knots 619 on site. The resulting configuration from theknotted construction can result in the connecting filament 617 having afolded width that is greater than the diameter of the axial bore 616even when compressed so that the connecting filament 617 does not passthrough the bore 616 when tension is applied to the repair filament 620approximately in a direction T. As shown in FIG. 7B, the device 610 canbe implanted in a bore 1002 formed in bone 1001, and the depth of thebore 1002 can be such that a distance between the distal end 612 d ofthe anchor 612 and the bottom of the bore 1002 is relatively small, inthe range of about 1 millimeter to about 15 millimeters.

FIGS. 8A and 8B illustrate still another exemplary embodiment of asurgical soft tissue repair device 710 that includes a hard anchor 712having an axial bore 716 formed therethrough, a repair filament 720, anda connecting filament 717. As shown, portions of the connecting filament717 are glued together to form a loop and the repair filament 720 canpass through a center 718 of the loop approximately at or adjacent to adistal end 712 d of the anchor 712. The resulting loop can be sized suchthat in this folded configuration it cannot pass through the axial bore716. As shown, the diameter of the loop is greater than the diameter ofthe axial bore 716. Further, because the connecting filament 717 can beflexible, even when the continuous loop is compressed such that a leftside of the loop contacts the right side of the loop, the resultingfolded width of the connecting filament 717 can still be larger than thediameter of the axial bore 716 so that the connecting filament 717 doesnot pass through the bore 716 when tension is applied to the repairfilament 720 approximately in a direction T. In one embodiment a widthof the strand of filament in an unfolded configuration used to form theglued loop is less than a diameter of the bore 716. This allows thestrand in the unfolded configuration to be passed through the bore 716from a proximal end of the bore 716 to a distal end of the bore 716 whenfirst constructing the device 710 and then subsequently glued to formthe loop, i.e., the folded configuration, thereby preventing the strandfrom being passed back through the bore 716 when tension is applied tothe repair filament 720 approximately in the direction T. As shown inFIG. 8B, the device 710 can be implanted in a bore 1002 formed in bone1001, and the depth of the bore 1002 can be such that a distance betweenthe distal end 712 d of the anchor 712 and the bottom of the bore 1002is relatively small, in the range of about 1 millimeter to about 15millimeters.

FIGS. 9A and 9B illustrate yet another exemplary embodiment of asurgical soft tissue repair device 810 that includes a hard anchor 812having an axial bore 816 formed therethrough, a repair filament 820, anda connecting filament 817. As shown, the connecting filament 817 piercesthrough itself multiple times to form a continuous loop, i.e., a foldedconfiguration, and the repair filament 820 can pass through a center ofthe loop approximately at or adjacent to a distal end 812 d of theanchor 812. The resulting configuration can result in the connectingfilament 817 having a folded width that is greater than the diameter ofthe axial bore 816 even when compressed so that the connecting filament817 does not pass through the bore 816 when tension is applied to therepair filament 820 approximately in a direction T. As shown in FIG. 9B,the device 810 can be implanted in a bore 1002 formed in bone 1001, andthe depth of the bore 1002 can be such that a distance between thedistal end 812 d of the anchor 812 and the bottom of the bore 1002 isrelatively small, in the range of about 1 millimeter to about 15millimeters.

FIGS. 10A and 10B illustrate another exemplary embodiment of a surgicalsoft tissue repair device 910 that includes a hard anchor 912 having anaxial bore 916 formed therethrough, a repair filament 920, and aconnecting filament 917. As shown, the connecting filament 917 is of anature similar to the connecting filament described above with respectto FIGS. 2A and 2B except rather than having the repair filament 920disposed around the connecting filament 917 the repair filament 920 isdisposed through the connecting filament 917 approximately at oradjacent to a distal end 912 d of the anchor 912. A width formed by twoportions of the connecting filament 917 being compressed together issuch that the folded width is greater than the diameter of the axialbore 916 so that the connecting filament 917 does not pass through thebore 916 when tension is applied to the repair filament 920approximately in a direction T. Further, in some embodiments a width ofthe connecting filament 917 in an uncompressed and unfolded state can beless than a diameter of the bore 916 such that the connecting filament917 can be moved to the distal end 912 d of the anchor 912 by passingthe connecting filament 917 distally through the bore 916, for instancewhen first constructing the device 910. As shown in FIG. 10B, the device910 can be implanted in a bore 1002 formed in bone 1001, and the depthof the bore 1002 can be such that a distance between the distal end 912d of the anchor 912 and the bottom of the bore 1002 is relatively small,in the range of about 1 millimeter to about 15 millimeters.

FIGS. 11A and 11B illustrate still another exemplary embodiment of asurgical soft tissue repair device 1010 that includes a hard anchor 1012having an axial bore 1016 formed therethrough, a repair filament 1020,and a connecting filament 1017. As shown, the connecting filament 1017is disposed within a distal side 1012 d of the anchor 1012. By way ofnon-limiting example, the anchor 1012 can include bores or otherstructures for receiving ends of the connecting filament 1017 tomaintain a general location of the connecting filament 1017, which inturn can maintain a general location of the repair filament 1020 withrespect to the anchor 1012 due to the repair filament 1020 being coupledto the connecting filament 1017. The configuration of the device 1010 ingeneral can be such that the attachment of the connecting filament 1017to the anchor 1012 by way of bores or other structures for receivingends of the connecting filament 1017 does not carry the load resultingfrom tissue attachment. In the illustrated embodiment the repairfilament 1020 is passed around the connecting filament 1017, but inother embodiments the repair filament 1020 can pass through theconnecting filament 1017. Because the connecting filament 1017 isgenerally held in place at the distal side 1012 d of the anchor 1012,the connecting filament 1017 does not pass through the bore 1016 whentension is applied to the repair filament 1020 approximately in adirection T. As shown in FIG. 11B, the device can be implanted in a bore1002 formed in bone 1001. While in some instances the connectingfilament 1017 can be secured to the anchor 1012 prior to implantation,in other instances the fit of the anchor 1012 in the bore 1002 cangenerally maintain the location of the connecting filament 1017 withrespect to the anchor 1012 to prevent the connecting filament 1017, andthus the repair filament 1020, from falling away from the anchor 1012.

FIGS. 12A and 12B illustrate yet another exemplary embodiment of asurgical soft tissue repair device 1110 that includes a hard anchor 1112having an axial bore 1116 formed therethrough, a repair filament 1120,and a connecting filament 1117. As shown, the connecting filament 1117is located approximately at a distal end 1112 d of the anchor 1112 withthe repair filament 1120 being looped around it. In other embodimentsthe repair filament 1120 can pass through the connecting filament 1117.The location of the connecting filament 1117 with respect to the anchor1112 can be maintained, for example, by a guide (not illustrated)disposed around the anchor 1112, as described in greater detail belowwith respect to FIGS. 17-19E. Because the connecting filament 1117 isgenerally held in place at the distal side 1112 d of the anchor 1112,the connecting filament 1117 does not pass through the bore 1116 whentension is applied to the repair filament 1120 approximately in adirection T. As shown in FIG. 12B, the device can be implanted in a bore1002 formed in bone 1001. As illustrated the connecting filament 1117can become impinged between the anchor 1112 and walls of the bore 1002to generally maintain the location of the connecting filament 1117 withrespect to the anchor 1112 to prevent the connecting filament 1117, andthus the repair filament 1120, from falling away from the anchor 1112.In some embodiments the connecting filament 1117 can generally conformto the shape of the anchor 1112, as shown.

Although FIGS. 6-12B illustrate the engagement between the respectiverepair filaments and connecting filaments to be approximately at ordistal to the distal ends of the respective anchors, it is understoodthat tension applied to the repair filaments can cause the location ofthe engagement between the repair filaments and the connecting filamentsto shift proximally to a position slightly adjacent to the distal endsof the respective anchors.

FIGS. 13A and 13B illustrate another exemplary embodiment of a surgicalsoft tissue repair device 1210 that includes a hard anchor 1212 havingan axial bore 1216 formed therethrough, a repair filament 1220, and aconnecting filament 1217. The axial bore 1216 can be stepped such that adistal end 1216 d of the bore 1216 has a diameter that is greater than aremaining portion of the bore 1216. As shown, the connecting filament1217 is of a nature similar to the filaments 417, 417′, and 917described above with respect to FIGS. 6A, 6B, 10A, and 10B, and in theillustrated embodiment the repair filament 1220 is disposed around theconnecting filament 1217 approximately at or adjacent to a distal end1212 d of the anchor 1212. Similar to FIGS. 6-12B, tension applied tothe repair filament 1220 can cause the location of the engagementbetween the repair filament 1220 and the connecting filament 1217 toshift slightly proximally. A width of the connecting filament 1217 whentwo portions thereof are compressed together is such that the connectingfilament 1217 can be disposed within the stepped portion at the distalend 1216 d of the bore, but it is greater than the diameter of theremaining portion of the axial bore 1216 so that the connecting filament1217 does not pass through the bore 1216 when tension is applied to therepair filament 1220 approximately in a direction T. As shown in FIG.13B, the device 1210 can be implanted in a bore 1002 formed in bone1001, and the depth of the bore 1002 can be such that a distance betweenthe distal end 1212 d of the anchor 1212 and the bottom of the bore 1002is relatively small, in the range of about 1 millimeter to about 15millimeters.

A person skilled in the art will recognize that the connecting filamentconfigurations described herein for maintaining a location of repairfilament with respect to an anchor are only a sample of a wide varietyof configurations that can be used to achieve the same results. Theconnecting filament can have any number of shapes and configurationsthat assist in maintaining a location of the repair filament withrespect to an anchor for use in soft tissue repair without departingfrom the spirit of the present disclosure. Likewise, the connectingfilament can be formed using a variety of filament types, including butnot limited to a cannulated filament, a braided filament, and a monofilament. The type, size, and strength of the filament can depend, atleast in part, on the other materials of the anchor and repair filament,the obstructions through which it may pass, the type of configurationplanned for the connecting filament, and the type of procedure in whichthe connecting filament is used. Generally, the connecting filament hasa diameter that is larger than the diameter of the repair filament.Further, the diameter of the connecting filament is such that in certainconfigurations, such as altered, folded configurations, it is unable topass through a bore of an anchor, for instance because the width formedby the connecting filament is larger than the diameter of the bore ofthe anchor. In one exemplary embodiment the connecting filament isformed from a #2 filament (about 23 gauge to about 24 gauge), such as anOrthocord™ filament that is commercially available from DePuy Mitek,Inc. or Ethibond™ filament available from Ethicon Inc. In someembodiments the connecting filament can have a size between about a #4filament (about 21 gauge to about 22 gauge) and about a #4-0 filament(about 32 gauge to about 34 gauge). A length of the connecting filamentcan be in the range of about 2 millimeters to about 25 millimeters, andin one embodiment the length is about 10 millimeters.

While the present disclosure provides a number of differentconstructions and configurations for surgical soft tissue repairdevices, including various configurations of repair filaments,connecting filaments, and anchors, a person skilled in the art willrecognize a variety of other constructions the device, the anchor, therepair filament, and the connecting filament can have without departingfrom the spirit of the present disclosure.

Use of Soft Tissue Repair Devices

FIGS. 14A-14G illustrate one exemplary method for performing a tissuerepair using the repair construct illustrated in FIG. 1. A surgicalopening can be formed through skin 1000 and a cannula can be passedtherethrough to access a surgical repair site according to well knowntechniques. Although cannulas are often used to define a channel throughwhich the procedure can be performed, the cannula is not shown in FIGS.14A-14G for clarity of illustration. Accordingly, to the extent thefigures show components of the systems and devices passing through skin1000, these components would typically extend through the cannula, whichitself is passed through the skin 1000. Further, although the devicesand methods described herein are particularly useful for minimallyinvasive surgery, such as arthroscopic surgery, they can also be used inopen surgical procedures. After a surgical opening is formed throughskin 1000, a bore 1002 for inserting the device 310 can be formed inbone 1001 at the surgical repair site using techniques known to thosehaving skill in the art.

As shown in FIG. 14A, the connecting filament 317 can be distal of thesnare assembly 320 (or other connecting filament), and more particularlycan be placed in the axial bore 316 with its distal end 317 d in thedistal end 316 d of the bore 316. The anchor 312 can be fixated into thebore 1002 using ordinary techniques, such as with a driver that screwsor taps the anchor 312 into place. The snare assembly 320 and theconnecting filament 317 can be coupled before, during, or after fixationof the anchor 312 into the bore 1002, and in one exemplary embodimentthe snare assembly 320 is looped through the connecting filament 317prior to inserting the anchor 312 into the bore 1002. In the illustratedembodiment the connecting filament 317 is not fixedly coupled to theanchor 312, but because a diameter of the bore 316 is barely larger thana width formed by the loop of the connecting filament 317, generally theconnecting filament 317 can remain disposed within the bore 316. Thedistal end 317 d of the connecting filament 317 can then be brought intoan anchored configuration in which it engages the distal end 316 d ofthe bore 316 by applying tension to the repair filament 320approximately in a direction T. The tension can be applied by thesurgeon during the procedure and by the tissue during and after theprocedure is completed. In the anchored configuration, the connectingfilament 317 couples the repair filament 320 to the anchor 312. Inalternative embodiments, the anchor 312 can include one or more couplingfeatures for receiving the connecting filament 317 to maintain alocation of the connecting filament 317 with respect to the anchor 312.

As shown in FIG. 14B, the terminal end 324 of the repair filament 320can be passed into and through at least a portion of tissue 1003detached from the bone 1001. Optionally, a needle or similar tool ordevice can be coupled to the terminal end 324 to assist with threadingthe repair filament 320 through the tissue 1003. Likewise, othershuttling techniques known to a person skilled in the art can also beused to pass the snare assembly through the tissue.

As shown in FIGS. 14C and 14D, a portion of the terminal end 324 can bepassed through the opening 332 of the snare 330 and the snare 330 can becollapsed or dressed in a manner consistent with its snare type. Thus,in the illustrated embodiment the snare 330 can be collapsed by movingthe knot that forms the snare 330 away from the terminal end 324.

As shown in FIG. 14E, tension can be applied to the terminal end 324 bypulling approximately in a direction D, thereby causing the collapsedsnare 330 to slide distally toward the tissue 1003 in a zip line-likemanner until the snare 330 is adjacent to the tissue 1003. This, inturn, can cause the tissue 1003 to move toward and into contact with thebone 1001. Alternatively, tension can be applied to the terminal end 324before the snare 330 is dressed and after the snare 330 is adjacent tothe tissue 1003, or some combination of the two actions can be used,such as partially dressing the snare 330 before zip-lining it toward thetissue 1003. As shown in FIG. 14E, in embodiments that include thesleeve 350, as the snare 330 is slid distally toward the tissue 1003,the sleeve 350 can move proximally, out of the body. The sleeve 350, ifincluded, can be removed at any time, as shown in FIG. 14F for example.Final tensioning can be carried out by applying tension to the terminalend 324, or the sleeve 350 if it remains associated with the snareassembly.

As shown in FIG. 14G, one or more half-hitches can be formed proximateto the collapsed snare to allow for incremental or ratchet-liketensioning and/or to maintain a location of the collapsed snare. After afirst half-hitch is formed, the repair filament 320 can be furthertensioned in an incremental or ratchet-like manner by applying tensionto the repair filament 320. The addition of a second or morehalf-hitches can lock the location of the collapsed snare. Excessfilament can then be trimmed and removed to complete the procedure.Other techniques known to those skilled in the art can be used tomaintain the location of the collapsed snare, and thus the approximatedtissue.

FIGS. 15A-15G illustrate one exemplary method for performing a tissuerepair using the repair construct illustrated in FIG. 2A. A surgicalopening can be formed through skin 1000 and a cannula can be passedtherethrough to create a surgical repair site according to well knowntechniques. Similar to FIGS. 14A-14G, although cannulas are often usedto define a channel through which the procedure can be preformed, thecannula is not shown in FIGS. 15A-15G for clarity of illustration.Accordingly, to the extent the figures show components of the systemsand devices passing through skin 1000, these components would typicallybe extending through the cannula, which itself is passed through theskin 1000. After a surgical opening is formed through skin 1000, a bore1002 for inserting the device 410 can be formed in bone 1001 at thesurgical repair site using techniques known to those having skill in theart.

In the illustrated embodiment of FIG. 15A, the repair filament 420 isnot fixedly coupled to the anchor 412, but because a diameter of thebore 416 is barely larger than a width formed by the two portions of therepair filament 420 disposed therein, generally the repair filament 420can remain disposed within the bore 416. Alternatively, the repairfilament 420 can be held in place by an insertion tool. Further, theconnecting filament 417 can be brought into an anchored configuration inwhich the connecting filament 417 engages but does not pass through thebore 416 on the distal side 412 d of the anchor 412 by applying tensionto the repair filament 420 approximately in a direction T. The tensioncan be applied by the surgeon during the procedure and by the tissueduring and after the procedure is completed. In the anchoredconfiguration, the connecting filament 417 couples the repair filament412 to the anchor 420 approximately at or adjacent to the distal end 412d of the anchor 412. In alternative embodiments, the anchor 412 caninclude one or more coupling features for receiving the connectingfilament 417 to maintain a location of the connecting filament 417 withrespect to the anchor 412.

Once the device 410 is disposed in the bore 1002, it can then beoperated in a manner similar to as described with respect to FIGS.14B-14G. Thus, at least a portion of the terminal end 424 of the repairfilament 420 can be passed through at least a portion of the tissue 1003and through the opening 432 in the snare 430 and the snare 430 can becollapsed or dressed, for instance by moving the knot that forms thesnare 430 away from the terminal end 424. The snare 430 can be sliddistally toward the tissue 1003 by applying tension to the terminal end424 approximately in a direction F, which can result in the snare 430being adjacent to the tissue 1003 and the tissue 1003 moving towards thebone 1001. Final tensioning and removal of the sleeve 450, if used, canoccur, and one or more half-hitches can be formed proximate to thecollapsed snare 430 to allow for incremental or ratchet-like tensioningand/or to maintain a location thereof. Excess filament can then betrimmed and removed to complete the procedure.

Procedures that use the devices and systems described herein canwithstand both high levels of load that result from tissue and bonemovement after the procedure is completed and high levels of load thatcan occur while the procedure is being performed. For example,procedures that use devices such as the devices 310 and 410 canwithstand levels of load approximately in the range of about 2 kilogramsand about 50 kilograms, and in one embodiment can withstand levels ofload of about 15 kilograms.

Insertion Assembly and use Thereof

FIGS. 16-19E illustrate one exemplary way by which a surgical softtissue repair device can be implanted in bone. The surgical soft tissuerepair device 1310 illustrated in FIG. 16 has a construction similar tothe device 1110 described with respect to FIGS. 12A and 12B in that itincludes a hard anchor 1312 having an axial bore 1316 formedtherethrough, a repair filament 1320, and a connecting filament 1317,with the connecting filament 1317 being located at a distal side 1312 dof the anchor 1312 and the repair filament 1320 being disposed aroundthe connecting filament 1317. A diameter of the axial bore 1316 can bebarely larger than a width formed by the two portions of the repairfilament 1320 disposed in the bore 1316., and the repair filament 1320can be slidably coupled to the connecting filament 1317 such that it canmove distally approximately in a direction K and proximallyapproximately in a direction L as illustrated by the arrows in FIG. 16without falling away from the anchor 1312. Alternatively, the repairfilament 420 can be held in place by an insertion tool. In otherembodiments the repair filament 1320 can pass through the connectingfilament 1317. The location of the connecting filament 1317 with respectto the anchor 1312 can be maintained, for example, by a guide (notillustrated) disposed around the anchor, as described in greater detailbelow with respect to FIGS. 17-19E.

The device 1310 can be removably coupled to an insertion tool 1370configured to assist in placing the anchor 1312 in bone. As shown inFIG. 17, the insertion tool 1370 can be in the form of an elongate tubethat includes a proximal end 1370 p having a handle 1372, a distal end1370 d configured to mate with the anchor 1312, and a bore 1376extending through the insertion tool 1370 to allow the repair filament1320 to extend therethrough. The handle 1372 can be manipulated by asurgeon to move the insertion tool 1370, and thus the anchor 1312coupled thereto, in both a proximal direction and a distal direction.While a number of different configurations can be used to couple theanchor 1312 to the insertion tool 1370, in the illustrated embodimenttension is applied to the repair filament 1320 approximately in adirection T by tucking a proximal portion 1320 p of the repair filament1320 into a receiving feature of the handle 1372. A proximal end 1312 pof the anchor 1312 thus abuts the distal end 1370 d of the insertiontool 1370, rendering the anchor 1312 removably coupled to the insertiontool 1370. In alternative configurations, any number of removable matingtechniques and/or configurations can be used to allow the anchor 1312 tobe removably coupled to the insertion tool 1370. By way of non-limitingexample, the proximal end 1312 p of the anchor 1312 can be removablycoupled to the distal end 1370 d of the insertion tool 1370 by amale-female coupling feature that can be easily connected anddisconnected by a surgeon from the proximal end 1370 p of the insertiontool 1370.

The insertion tool 1370 can have a variety of shapes and configurations,as can the components thereof, depending at least in part on the sizeand shape of the device 1310 and other components with which theinsertion tool 1370 is used. The insertion tool 1370 can generally beconfigured in a manner that is complementary to the design of the device1310. For example, in the illustrated embodiment, the distal end 1370 dof the insertion tool 1370 is generally flat and has a diameter similarto the diameter of the anchor 1312, and the diameter of the insertiontool bore 1376 is similar to the diameter of the anchor bore 1316 sothat the two bores 1376, 1316 can be substantially aligned in use. Ofcourse, there is no requirement that these configurations becomplementary provided the two components can be adequately coupled forpurposes of inserting the device 1310 into bone. In some embodiments theinsertion tool 1370 can have a diameter in the range of about 1millimeter to about 12 millimeters, and in one embodiment it has adiameter of about 2 millimeters, and in some embodiments it can have alength in the range of about 5 centimeters to about 40 centimeters, andin one embodiment it has a length of about 25 centimeters. Any number ofmaterials known to those skilled in the art for forming insertion toolsand handles can be used to form the insertion tool 1370 and handle 1372,including but not limited to polymers and metals. In one exemplaryembodiment the insertion tool 1370 is formed from stainless steel andits handle 1372 is formed from polycarbonate.

As shown in FIG. 18, an insertion assembly 1300 can include the device1310, the insertion tool 1370, a guide portion 1380, and a spacerelement 1390, and can be used to place the device 1310 in bone. Theguide portion 1380 can be an elongate tube that is disposed around atleast a portion of the insertion tool 1370 and a portion of the anchor1312. As a result, as shown in FIG. 18, a distal portion 1380 d of theguide portion 1380 can hold the connecting filament 1317 against theanchor 1312 in embodiments of the device 1312 in which the connectingfilament 1317 would otherwise fall distally due to gravity. The guideportion 1380 can also be used to align the device 1310 and the insertiontool 1370 with the bore of the bone in which the device 1310 is to bedisposed, as described in further detail below with respect to FIGS.19A-19E. A proximal end 1380 p of the guide portion 1380 can include ahandle 1382 that can be used by a surgeon to grip the guide portion 1380and can also provide additional support for the spacer 1390 to sit on asshown.

The spacer element 1390 can be any removable component configured tomaintain a space between the handle 1372 of the insertion tool 1370 andthe handle 1382 of the guide portion 1380 when the spacer element 1390is disposed between the insertion tool 1370 and the guide portion 1380.The spacer element 1390 can prevent the insertion tool 1370 from beingmoved distally. Such distal movement by the insertion tool would causethe anchor 1312 to move distally into the bore 1002. Consequently,removal of the spacer element 1390 can allow the insertion tool handle1372 to be moved toward the guide portion handle 1382 to insert theanchor 1312 into the bore, as described in greater detail below withrespect to FIGS. 19A-19E. In the illustrated embodiment the spacer 1390is a tubular block adapted to sit primarily on one side of the insertiontool 1370, although in other embodiments the spacer can sit primarily onthe other side of the insertion tool 1370 or substantially on both sidesof the insertion tool 1370. A person skilled in the art would recognizea number of other components and configurations that can be used inplace of the spacer element 1390 to allow for selective movement of theinsertion tool 1370 toward the guide portion 1380 to move the device1310 distally into the bore 1002.

The guide portion 1380 and spacer element 1390 can have a variety ofshapes and configurations, depending at least in part on the shapes anddimensions of the insertion tool 1370, the device 1310, and thecomponents thereof. By way of non-limiting example, a diameter of theguide portion 1380 can typically be just larger than a diameter of theinsertion tool 1370 so that a connecting filament 1317 disposedtherebetween can be held in place. In some embodiments the guide portion1380 can have a diameter in the range of about 1 millimeters to about 13millimeters, and in one embodiment it has a diameter of about 2.5millimeters, and can have a length in the range of about 7 centimetersto about 50 centimeters, and in one embodiment it has a length of about30 centimeters. A length of the spacer element 1390 can be configuredbased on the desired insertion depth of the anchor 1312 into the bore1002 because once the spacer element 1390 is removed, the insertion tool1370 can slide distally until the insertion tool handle 1372 abuts theguide portion handle 1382. The distance traveled by the insertion tool1370 can also be the distance traveled by the anchor 1312 coupledthereto. Thus, if it is desired that a proximal end 1312 p of the anchor1312 is substantially flush with a surface of the bone, a length of thespacer element 1390 can be approximately equal to a length of the anchor1312 less any length of the anchor 1312 that extends distally beyond theguide portion 1380 when the guide portion 1380 is disposed around theanchor 1312. In some embodiments the spacer element 1390 can have alength in the range of about 3 millimeters to about 25 millimeters, andin one embodiment it has a length of about 10 millimeters. A personskilled in the art would recognize other configurations that can be usedwith respect to the device 1310, insertion tool 1370, and guide portion1380 to achieve desired insertion depths without departing from thespirit of the present disclosures. Further, any number of materialsknown to those skilled in the art for forming guide portions and spacerelements can be used to form the guide portion 1380, its handle 1382,and the spacer element 1390, including but not limited to polymers andmetals. In one exemplary embodiment both the guide portion 1380 and thespacer element 1390 are formed from stainless steel, while the guideportion handle 1382 is formed from polycarbonate.

FIGS. 19A-19E illustrate one exemplary method for performing a tissuerepair using the insertion assembly 1300 to insert the device 1310 intoa bore 1002 formed in bone 1001. A surgical opening can be formedthrough skin and a cannula can be passed therethrough to access asurgical repair site according to well known techniques. Similar toFIGS. 5A-5G, although cannulas are often used to define a channelthrough which the procedure can be preformed, the cannula is not shownin FIGS. 19A-19E for clarity of illustration. Accordingly, to the extentthe figures show components of the systems and devices passing throughskin, these components would typically be extending through the cannula,which itself is passed through the skin.

The bore 1002 can be formed in the bone 1001 in which the device 1310 isto be disposed using techniques known to those having skill in the art.As shown in FIG. 19A, once the insertion assembly 1300 is assembled bycoupling the anchor 1312 to the insertion tool 1370, disposing the guideportion 1380 around the insertion tool 1370, and disposing the spacerelement between the guide portion 1380 and the insertion tool 1370, theassembly 1300 can be moved to a location that is proximate to the bore1002 for insertion of the device 1310 therein. As shown in FIG. 19B, thedistal end 1380 d of the guide portion 1380 can abut each side of thebone 1001 adjacent to the bore 1002, while the distal side 1312 d of theanchor 1312 can be inserted into the bore 1002. The connecting filament1317 can be disposed between the distal side 1312 d of the anchor 1312and the walls of the bore due to the guide portion 1380 maintaining theends of the connecting filament 1317 between the guide portion 1380 andthe anchor 1312.

As shown in FIG. 19C, the spacer element 1390 can be removed, and thenas shown in FIG. 19D, the insertion tool 1370 can be advanced distallyto move the anchor 1312 into the bore 1002. Distal travel of theinsertion tool 1370 stops when the insertion tool handle 1372 abuts theguide portion 1382, resulting in the proximal end 1312 p of the anchorbeing substantially flush with the bone 1001. In the illustratedembodiment the distance traveled by the anchor 1312 is the approximatelength of the spacer element 1390. Because the guide portion 1380 abutsthe bore 1002 as the insertion tool 1370 travels distally, as the anchor1312 slides further out of the guide portion 1380 and into the bore1002, the connecting filament 1317 can remain disposed adjacent to theanchor 1312, between the anchor 1312 and the walls of the bore 1002. Asshown in FIG. 19E, the guide portion 1380 and insertion tool 1370 can beremoved, leaving the device 1310 disposed in the bone 1001 with alocation of the repair filament 1320 with respect to the anchor 1312being substantially maintained by the connecting filament 1317 trappedbetween the anchor 1312 and the walls of the bore 1002. The repairfilament 320 can subsequently be used to repair soft tissue as describedabove, or using other procedures known to those skilled in the artand/or described in other patent applications incorporated by referenceherein.

The procedures discussed herein are just some examples of proceduresthat can be performed in conjunction with systems, devices, and methodsdisclosed herein. A person skilled in the art will recognize a number ofother ways that the disclosed systems, devices, and methods can be usedin various other configurations and types of surgical procedures.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims.

Further, although the systems, devices, and methods provided for hereinare generally directed to surgical techniques, at least some of thesystems, devices, and methods can be used in applications outside of thesurgical field. All publications and references cited herein areexpressly incorporated herein by reference in their entirety.

What is claimed is:
 1. A surgical soft tissue repair device, comprising:an anchor configured to be fixated in bone and having at least one boreextending therethrough; a repair filament; and a connecting filament insliding engagement with the repair filament approximately at or adjacentto a distal end of the anchor, the connecting filament effective toconnect the repair filament to the anchor.
 2. The device of claim 1,wherein the anchor is a rigid anchor.
 3. The device of claim 1, whereinthe repair filament comprises a snare assembly having a collapsiblesnare at one end thereof and a terminal end opposite the collapsiblesnare, and the anchor is positioned at an intermediate location on therepair filament between the collapsible snare and the terminal end. 4.The device of claim 1, wherein the bore is one of an axial bore and atransverse bore.
 5. The device of claim 4, wherein the bore is an axialbore that is stepped having a first, smaller diameter at a proximal endthereof and a second, greater diameter at a distal end thereof.
 6. Thedevice of claim 1, wherein the connecting filament has a foldedconfiguration in which the connecting filament is unable to pass throughthe bore.
 7. The device of claim 1, wherein the connecting filamentcomprises at least one of a continuous loop and a knot.
 8. The device ofclaim 1, wherein the repair filament slidably engages with theconnecting filament by passing therethrough.
 9. The device of claim 1,wherein the connecting filament is held by the anchor.
 10. The device ofclaim 1, wherein the connecting filament does not couple to the anchor.11. The device of claim 1, wherein the connecting filament has a firstconfiguration in which it is able to pass through the bore of the anchorand a second configuration in which it is unable to pass through thebore of the anchor and is effective to secure the repair filament to theanchor.
 12. The device of claim 1, further comprising an insertion toolremovably coupled to the anchor, the insertion tool having at least onebore extending therethrough, the at least one bore of the insertion toolbeing substantially aligned with the at least one bore of the anchor.13. A surgical repair method, comprising: inserting an anchor into ahole in a bone at a location proximate to detached soft tissue, theanchor having a bore extending therethrough and anchor being coupled toa snare assembly by a connecting filament that is disposed in oradjacent to the bore at a position distal to the snare assembly, thesnare assembly having a collapsible snare at one end thereof and atleast one elongate filament extending therefrom, the at least oneelongate filament having a terminal end opposite the collapsible snare;passing at least one of the snare and the terminal end of the elongatefilament through at least a portion of the detached soft tissue;inserting the terminal end of the elongate filament through the snare;collapsing the snare around the elongate filament; and sliding thecollapsed snare toward the soft tissue to apply tension to filamentbetween the anchor and the tissue so as to bring the tissue intoproximity with the bone.
 14. The method of claim 13, wherein at least aportion of the connecting filament is disposed within the bore.
 15. Themethod of claim 13, wherein at least a portion of the snare assembly isdisposed within the bore and the connecting filament is disposed on aside of the bore opposite to the snare assembly.
 16. The method of claim13, further comprising tensioning the snare assembly to configure theconnecting filament in a connecting configuration in which theconnecting filament is unable to pass through the bore to fix tissuerelative to the bone.
 17. The method of claim 13, wherein the connectingfilament is slidably coupled to the repair filament approximately at oradjacent to a distal end of the anchor.
 18. The method of claim 13,further comprising actuating the connecting filament to move from afirst configuration in which it is able to pass through the bore of theanchor to a second configuration in which it is unable to pass throughthe bore of the anchor and is effective to secure the repair filament tothe anchor.